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510(k) K812097

Device
KOI LACREMAL HOOK & DILATOR
Applicant
KOI, INC.
510(k) number
K812097
Product code
HNW  
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-18
Date received
1981-07-24
Regulation
886.4350
Classification name
Dilator, Lachrymal
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862070INTER-SHARPIntermedics Intraocular, Inc.1986-06-17
K841002LACHRYMAL PROBES-VARIOUSPremier Dental Products Co.1984-05-09

Legacy Summary#

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FDA Review#

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